Neopharm Study Can Continue
By TSC Staff
12/27/2005 8:45 AM EST
A phase 3 trial of Neopharm's (NEOL:Nasdaq - commentary - research - Cramer's Take) cintredekin besudotox treatment for aggressive brain cancer can continue after initial data from the study was reviewed by an independent committee.
Shares of the Waukegan, Ill., biotech soared $3.43, or 43%, to $11.38 on the news.
The data monitoring committee overseeing the trial has "met, analyzed, and reviewed the data for the trial's second futility analysis, and has recommended that [the study] continue as planned under the approved protocol," Neopharm said. As a result, the company ended enrollment in the study.
Cintredekin besudotox, aimed at Glioblastoma Multiforme, the most aggressive form of brain cancer, is a recombinant protein composed of a tumor-targeting molecule and a cytotoxic agent. The drug is delivered using catheters placed following tumor removal in areas with microscopic tumor spread or at risk of tumor spread around the tumor cavity.
According to Neopharm, 294 patients were enrolled in the trial, including 276 patients with confirmed recurrent GBM. The enrolled patients will continue to be monitored as the trial progresses towards the interim efficacy analysis at 160 deaths and the final efficacy analysis at 215 deaths, if necessary. The events are currently estimated to occur late in the second quarter of 2006, and late in the fourth quarter of 2006 or early 2007, respectively.
The study is looking for a statistically significant improvement in long-term patient survival over MGI Pharma's (MOGN:Nasdaq - commentary - research - Cramer's Take) Gliadel chemotherapy wafer.
"If results are considered statistically significant, the company, at that point, would evaluate its plans to proceed with a BLA submission. If necessary, a final analysis will be conducted after notification of 215 deaths, to demonstrate superiority (p less than or equal to 0.048) of long-term survival of cintredekin besudotox over Gliadel wafer.
The final analysis is currently expected to occur late in the fourth quarter of 2006 or early in 2007," Neopharm said.
thestreet.com
EDIT
More about their drug from another post ....
About Cintredekin Besudotox (IL13-PE38QQR)
Cintredekin besudotox is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (Interleukin-13, or IL13) and a cytotoxic agent (Pseudomonas Exotoxin, or PE). The drug is delivered via Convection Enhanced Delivery (CED), a novel drug delivery system using catheters placed following tumor resection (removal), in areas with microscopic tumor spread or at risk of tumor spread around the tumor resection cavity. IL13 receptors are present in appreciable numbers on malignant glioma cells, but only to a minimal amount if at all on healthy brain cells. The IL13 portion is designed to bind to receptors on tumor cells like a key fits into a lock. The cancer cell latches onto and absorbs the IL13 and the attached PE, causing destruction of the cancer cell. Healthy brain cells appear to be unharmed because they do not internalize the PE.
Promising data for this potential therapeutic advance in the treatment of GBM was observed in Phase I/II studies. In addition, the importance of adequate catheter positioning in order to achieve optimal distribution of cintredekin besudotox in brain tissue was assessed, leading to the specific guidelines for catheter positioning and deferred catheter placement used in the PRECISE Trial. This translated into a better patient outcome for the 45 recurrent GBM patients treated post-tumor resection in the Phase I/II studies, with an overall median survival of 44.0 weeks (95% Confidence Interval (CI): 36.1-52.4) including 42% of patients with less than 2 adequately positioned catheters, while patients with greater than or equal to 2 catheters adequately positioned surviving with a median of 51.7 weeks (95% CI: 36.1-78.0). Separately, 1-year and 2-year survival rates for recurrent GBM patients were 40% and 20% respectively.
Cintredekin besudotox has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). NeoPharm's cintredekin besudotox development program was also selected to participate in the FDA Continuous Marketing Application Pilot 2 Program.
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